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A randomized controlled trial comparing traditional plaster cast rehabilitation with functional walking boot rehabilitation for acute Achilles tendon ruptures |
Maempel JF, Clement ND, Duckworth AD, Keenan OJF, White TO, Biant LC |
The American Journal of Sports Medicine 2020 Sep;48(11):2755-2764 |
clinical trial |
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: There has been a shift toward functional nonoperative rehabilitation in the treatment of Achilles tendon rupture (ATR) despite a shortage of studies directly comparing nonoperative functional rehabilitation with traditional nonoperative immobilization. PURPOSE: To compare patient-reported outcome measures and functional outcomes for nonoperatively treated ATR with traditional cast immobilization or functional rehabilitation in a walking boot. STUDY DESIGN: Randomized controlled clinical trial; level of evidence, 2. METHODS: In a single-center nonblinded study, 140 patients were randomized to compare treatment for acute ATR in (1) an immobilizing cast in reducing degrees of equinus over a 10-week period with 8 weeks of nonweightbearing mobilization or (2) a walking boot for 8 weeks with reducing equinus and immediate full weightbearing. Exclusion criteria were delayed presentation > 2 weeks after injury, tendon reruptures, and latex allergy. Analysis was undertaken on an intention-to-treat basis. RESULTS: A total of 69 patients (median age 41 years (interquartile range 33 to 50.5 years)) were randomized to walking boot treatment and 71 patients (41 (32 to 49)) to cast treatment. At 6 months, patients treated in a walking boot reported better Short Musculoskeletal Function Assessment (SMFA) dysfunction index (6.62 (2.21 to 12.50) versus 10.66 (4.96 to 13.42); p = 0.050), SMFA bother index (7.29 (2.08 to 14.58) versus 10.42 (5.73 to 19.27); p = 0.04), Achilles Tendon Total Rupture Score (71.5 (53.50 to 84.25) versus 54.0 (37 to 76); p = 0.01), and Foot and Ankle Questionnaire core score (91 (81.89 to 97.55) versus 85 (78.25 to 92.09); p = 0.04). At 1 year, there was no difference in SMFA dysfunction index (2.21 (0.74 to 5.88) versus 2.94 (1.47 to 6.62); p = 0.25), SMFA bother index (2.08 (0 to 9.38) versus 5.21 (0.52 to 11.98); p = 0.25), Achilles Tendon Total Rupture Score (92 (72.50 to 96) versus 87.5 (66.0 to 94.75); p = 0.21), or Foot and Ankle Questionnaire core score (97.75 (89.46 to 99.00) versus 95.50 (90.88 to 97.50); p = 0.18). Rerupture occurred in 5 and 11 patients (p = 0.075) and venous thromboembolism in 2 and 3 patients (p = 0.67) in the boot and cast groups, respectively. Fifteen patients in the boot group but none in the cast group had skin problems (p < 0.001). Patients treated in a boot returned to driving at a median 12 weeks (versus 13 weeks for cast; p = 0.045), but there was no difference in time to return to work (p = 0.48). CONCLUSION: Functional rehabilitation with early weightbearing is a safe alternative to traditional immobilizing treatment for ATR, giving better early functional outcomes, albeit with a higher incidence of transient minor skin complications. REGISTRATION: NCT02598843 (ClinicalTrials.gov identifier).
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